Study Director

For each nonclinical laboratory study, a scientist or other professional of appropriate education, training, and experience, or combination thereof, shall be identified as the study director. The study director has overall responsibility for the technical conduct of the study, as well as for the interpretation, analysis, documentation and reporting of results, and represents the single point of study control. The study director shall assure that

1. The protocol, including any change, is approved as provided by Section 58.120 and is followed.

2. All experimental data, including observations of unanticipated responses of the test system are accurately recorded and verified.

3. Unforeseen circumstances that may affect the quality and integrity of the nonclinical laboratory study are noted when they occur, and corrective action is taken and documented.

4. Test systems are as specified in the protocol.

5. All applicable GLP regulations are followed.

6. All raw data, documentation, protocols, specimens, and final reports are transferred to the archives during or at the close of the study.

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